Monthly Archives: May 2018

In the area of guidance, FDA published three this week including one on sunscreens that has been in draft form since 2011. EMA published one on IMPs for consultation. HPRA, WHO, Health Canada and CDSCO each published one. Among the non-guidance publications this week, the MHRA inspectorate blog provides examples of data integrity failures in the GDP area. It [...]

A lite week for new guidance publications. Two each from FDA and EMA. Among the non-guidance publications are two of particular interest. One is a report of the drug approval times in the major health authority jurisdictions including some nice graphs and figures published by The Centre for Innovation in Regulatory Science. The second is an FDA report on [...]

A collection of both draft and final guidance from both the FDA and EMA published this week. Others also issued guidance including WHO, HPRA, Health Canada, TGA and CDSCO. Much to read! Also, the non-guidance publications continue from MHRA, EMA and FDA. Among this later collection are the MHRA GCP Inspection Metrics, Changes in the FDA IOM 2018 regarding [...]

We include another special, this one on the recently published MHRA 2018 Guidance on Data Integrity. Happy reading! Barbara FDA: ADMINISTRATIVE: The FR announced availability of the 14-page FDA PDUFA VI Benefit-Risk Implementation Plan for comment. ADMINISTRATIVE: FDA published a guidance, ‘Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act.’ [...]

Guidance documents were in modest supply this week, four from the FDA, four from EMA, two from Health Canada and two items from Pakistan. FDA also withdrew one final rule due to “significant adverse comments” received during the comment period ending April 11, 2018. This one is important. In the non-guidance area, we have the usual collection from the [...]

Guidance documents are available from the FDA and EMA this week across a variety of topics. Lots to read there from both the FDA and EMA. Enforcement publications were busy this week: three drug warning letters from FDA, of which two were to OTC manufacturers; two reports of EU GMP non-compliance; and two forms 483 from sites in India. [...]